Earlier this week the U.S. Food and Drug Administration reclassified transvaginal mesh implants, which are used to treat female pelvic organ prolapse as high-risk devices. These products must now go through a stringent approval process before being marketed and sold. Vaginal mesh products have contributed to serious complications in women, resulting in erosion and organ perforation, and causing many complaints by patients of pain and severe infection. The implants are now classified as a Class III devices. Thus, the FDA now needs to have more than just written support of the products’ safety as “substantially equivalent” to a product already approved by the FDA in order to be used and sold.
Vaginal mesh devices were previously approved through a much more lenient process in 2002 as Class II medical devices, meaning that several companies, including Johnson & Johnson’s unit Ethicon Inc. and Boston Scientific Corp, among others, were not required to perform any type of clinical testing to support the safety of the devices prior to releasing them on the market. The current cases against Ethicon, now numbering more than 23,000, allege that Ethicon did not provide adequate warnings of the dangers and severe risks of the devices when used to treat pelvic organ prolapse in women. The new requirements give companies that are already making the products about two and a half years to submit their premarket approval application while companies introducing new transvaginal mesh devices for pelvic organ prolapse must submit a premarket approval application before marketing the devices.
This reclassification was undertaken with hopes that it will help address the major risks associated with the surgical mesh implant, and ultimately to improve the lives of women suffering from pelvic organ prolapse. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, said in a statement Monday, “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”